CN108474773A - 胰岛素类似物的生物分析方法 - Google Patents

胰岛素类似物的生物分析方法 Download PDF

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Publication number
CN108474773A
CN108474773A CN201780007081.XA CN201780007081A CN108474773A CN 108474773 A CN108474773 A CN 108474773A CN 201780007081 A CN201780007081 A CN 201780007081A CN 108474773 A CN108474773 A CN 108474773A
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China
Prior art keywords
insulin
labeled
analog
insulin analog
method described
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Pending
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CN201780007081.XA
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English (en)
Chinese (zh)
Inventor
马德哈万·布德
穆克什·B·帕塔勒
阿南德·海德卡
拉尼坦德拉纳斯·泰戈尔
塞巴斯蒂安·阿拉斯泰尔·麦克唐纳
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Biocon Ltd
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Biocon Ltd
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/74—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12P—FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
    • C12P21/00—Preparation of peptides or proteins
    • C12P21/02—Preparation of peptides or proteins having a known sequence of two or more amino acids, e.g. glutathione
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/04—Preparation or injection of sample to be analysed
    • G01N30/06—Preparation
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/62—Detectors specially adapted therefor
    • G01N30/72—Mass spectrometers
    • G01N30/7233—Mass spectrometers interfaced to liquid or supercritical fluid chromatograph
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/58—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6803—General methods of protein analysis not limited to specific proteins or families of proteins
    • G01N33/6848—Methods of protein analysis involving mass spectrometry
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2330/00—Production
    • C12N2330/50—Biochemical production, i.e. in a transformed host cell
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2503/00—Use of cells in diagnostics
    • C12N2503/02—Drug screening
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/88—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
    • G01N2030/8809—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample
    • G01N2030/8813—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials
    • G01N2030/8831—Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86 analysis specially adapted for the sample biological materials involving peptides or proteins
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/46—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
    • G01N2333/47—Assays involving proteins of known structure or function as defined in the subgroups
    • G01N2333/4701—Details
    • G01N2333/4745—Insulin-like growth factor binding protein
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/575—Hormones
    • G01N2333/62—Insulins
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2458/00—Labels used in chemical analysis of biological material
    • G01N2458/15—Non-radioactive isotope labels, e.g. for detection by mass spectrometry
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S930/00—Peptide or protein sequence
    • Y10S930/01—Peptide or protein sequence
    • Y10S930/02—Containing modified or unusual amino acid
    • Y10S930/022—Containing radioactive atom

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Bioinformatics & Computational Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Endocrinology (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Biophysics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • General Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Other Investigation Or Analysis Of Materials By Electrical Means (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
CN201780007081.XA 2016-01-23 2017-01-20 胰岛素类似物的生物分析方法 Pending CN108474773A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN201641002615 2016-01-23
IN201641002615 2016-01-23
PCT/IB2017/050303 WO2017125885A1 (en) 2016-01-23 2017-01-20 Bio-analytical method for insulin analogues

Publications (1)

Publication Number Publication Date
CN108474773A true CN108474773A (zh) 2018-08-31

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Country Status (8)

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US (1) US20190212347A1 (de)
EP (1) EP3405785B1 (de)
JP (1) JP6893214B2 (de)
KR (1) KR20180103961A (de)
CN (1) CN108474773A (de)
AU (1) AU2017208935A1 (de)
CA (1) CA3010566A1 (de)
WO (1) WO2017125885A1 (de)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109991351A (zh) * 2019-03-27 2019-07-09 苏州旭辉检测有限公司 一种血液样本中胰岛素类似物的检测方法
CN116858978B (zh) * 2023-09-04 2023-12-26 军科正源（北京）药物研究有限责任公司 一种同时检测门冬胰岛素和德谷胰岛素的方法及其血浆样品处理方法

Citations (6)

* Cited by examiner, † Cited by third party
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EP1311707B1 (de) * 2000-08-25 2008-10-15 Genencor International, Inc. Massenspektrometrische analyse von biopolymeren
CN101291952A (zh) * 2005-10-13 2008-10-22 拜奥康有限公司 制备胰岛素缀合物的方法
CN101910841A (zh) * 2007-10-29 2010-12-08 佐治亚大学研究基金会 用于定量糖组学的体内同位素标记方法
CN103392219A (zh) * 2010-12-28 2013-11-13 探索诊断投资公司 通过质谱法定量胰岛素
CN103454433A (zh) * 2012-06-05 2013-12-18 许洋 一种新型检测内外源性胰岛素的免疫质谱试剂盒
CN104458890A (zh) * 2014-12-17 2015-03-25 中国计量科学研究院 一种同位素稀释质谱法测定胰岛素含量的方法

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JP4596207B2 (ja) * 2000-05-15 2010-12-08 味の素株式会社 酵素によるタンパク質の同位体標識法
US20030119109A1 (en) * 2001-07-26 2003-06-26 Van Den Burg Harrold Alfred Efficient 13C/15N double labeling of proteins in a methanol-utilizing strain (Mut+) of pichia pastoris
JPWO2004029254A1 (ja) * 2002-09-30 2006-01-26 味の素株式会社 安定同位体標識タンパク質の製造方法
CA2687946A1 (en) * 2007-05-23 2008-11-27 Nicholas A. Williamson Method of mass analysis of target molecules in complex mixtures
KR101492011B1 (ko) * 2008-02-06 2015-02-10 바이오콘 리미티드 발효 배지 및 이의 방법
US9134319B2 (en) * 2013-03-15 2015-09-15 The Regents Of The University Of California Method for replacing biomarkers of protein kinetics from tissue samples by biomarkers of protein kinetics from body fluids after isotopic labeling in vivo
US10324082B2 (en) * 2015-03-03 2019-06-18 Quest Diagnostics Investments Llc Methods for quantitation of insulin levels by mass spectrometry

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1311707B1 (de) * 2000-08-25 2008-10-15 Genencor International, Inc. Massenspektrometrische analyse von biopolymeren
CN101291952A (zh) * 2005-10-13 2008-10-22 拜奥康有限公司 制备胰岛素缀合物的方法
CN101910841A (zh) * 2007-10-29 2010-12-08 佐治亚大学研究基金会 用于定量糖组学的体内同位素标记方法
CN103392219A (zh) * 2010-12-28 2013-11-13 探索诊断投资公司 通过质谱法定量胰岛素
CN103454433A (zh) * 2012-06-05 2013-12-18 许洋 一种新型检测内外源性胰岛素的免疫质谱试剂盒
CN104458890A (zh) * 2014-12-17 2015-03-25 中国计量科学研究院 一种同位素稀释质谱法测定胰岛素含量的方法

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* Cited by examiner, † Cited by third party
Title
ALISTAIR D. KIPPEN，ET AL.: "Development of an Isotope Dilution Assay for Precise Determination of Insulin, C-peptide, and Proinsulin Levels in Non-diabetic andType II Diabetic Individuals with Comparison to Immunoassay", 《THE JOURNAL OF BIOLOGICAL CHEMISTRY》 *
ANGUS G JONES等: "Assessment of endogenous insulin secretion in insulin treated diabetes predicts postprandial glucose and treatment response to prandial insulin", 《BMC ENDOCRINE DISORDERS》 *
DIEGO RODRI´GUEZ-CABALEIRO,ET AL.: "Pilot Study for the Standardization of Insulin Immunoassays with Isotope Dilution–Liquid Chromatography/Tandem Mass Spectrometry", 《CLINICAL CHEMISTRY》 *

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Publication number Publication date
EP3405785B1 (de) 2020-04-29
AU2017208935A1 (en) 2018-08-30
EP3405785A4 (de) 2019-01-16
EP3405785A1 (de) 2018-11-28
US20190212347A1 (en) 2019-07-11
CA3010566A1 (en) 2017-07-27
JP6893214B2 (ja) 2021-06-23
KR20180103961A (ko) 2018-09-19
JP2019505786A (ja) 2019-02-28
WO2017125885A1 (en) 2017-07-27

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